title: Tolerance and acceptance results of a palladium-103 permanent breast seed implant Phase I/II study.
abstract: OBJECTIVE
  To test, in a prospective Phase I/II trial, a partial breast irradiation technique using a 103Pd permanent breast seed implant (PBSI) realized in a single 1-h procedure under sedation and local freezing.
  
  
  METHODS
  Eligible patients had infiltrating ductal carcinoma < or = 3 cm in diameter, surgical margin > or = 2 mm, no extensive intraductal component, no lymphovascular invasion, and negative lymph nodes. Patients received a permanent seed implant, and a minimal peripheral dose of 90 Gy was prescribed to the clinical target volume, with a margin of 1.5 cm.
  
  
  RESULTS
  From May 2004 to April 2007, 67 patients received the PBSI treatment. The procedure was well tolerated, with 17% of patients having significant pain after the procedure. Only 1 patient (1.5%) had an acute skin reaction (Grade 3 according to the National Cancer Institute Common Toxicity Criteria). The rates of acute moist desquamation, erythema, and indurations were 10.4%, 42%, and 27%, respectively. At 1 year the rate of Grade 1 telangiectasia was 14%. The rate of skin reaction decreased from 65% to 28% when skin received less than the 85% isodose. According to a Radiation Therapy Oncology Group questionnaire, 80-90% of patients were very satisfied with their treatment, and the remainder were satisfied. One patient (1.5%) developed an abscess, which resolved after the use of antibiotics. There was no recurrence after a median follow-up of 32 months (range, 11-49 months).
  
  
  CONCLUSIONS
  The feasibility, safety, and tolerability of PBSI compares favorably with that of external beam and other partial breast irradiation techniques.
authors.affiliation: Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada. Jean-Philippe.Pignol@sunnybrook.ca
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Pignol
authors.forename: Eileen
authors.initials: E
authors.lastname: Rakovitch
authors.forename: Brian M
authors.initials: BM
authors.lastname: Keller
authors.forename: Raxa
authors.initials: R
authors.lastname: Sankreacha
authors.forename: Carole
authors.initials: C
authors.lastname: Chartier
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods* / Q000523:psychology; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D018270:Carcinoma, Ductal, Breast / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D010165:Palladium / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011446:Prospective Studies; D011832:Radiation Injuries / Q000473:pathology; D011868:Radioisotopes / Q000627:therapeutic use*; D011879:Radiotherapy Dosage; D012867:Skin / Q000528:radiation effects
chemical_list: D011868:Radioisotopes; D010165:Palladium